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Biotech / Medical : Biotime-Nasdaq's best kept secret?
BTIM 0.00010000.0%Nov 5 1:26 PM EST
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To: Annie who wrote (912)5/7/1998 11:45:00 AM
From: Stephen How   of 1432
 
Is Asensio wrong here?

In his latest press release (May 7), Asensio writes:

"The fact is that regardless of Mr. Crossen and BioTime's false statements and claims, the FDA will not allow the use of Hextend without a limitation on dosage, and physicians will not use Hextend&reg beyond those limitations."

I don't believe there is a "dosage limitation" per se in the Dupont Pharma Hespan&reg package insert (http://btim.dyn.ml.org/Biotime/hespan.html). In the insert, in the Warnings section, there is a note on transient effects of hetastarch on the coagulation mechanism (see insert). In the Dosage and Administration section, under Dosage for Acute Use in Plasma Volume Expansion it reads only:

Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required, although higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred.

Asensio may not be literally correct in his statement.
I think the FDA allowed this wording in the Hespan&reg insert because of all the prior research showing no effects on coagulation, including a single study that safely applied 5 L hetastarch to 4 trauma patients in a 24h period, and 15 L to a single patient in 24h. In other words, it seems that the medical community has some vague understanding about the dosage limitations of hetastarch. However, as hetastarch induced coagulopathy is not 100% understood (or even agreed upon -- many researchers find no coagulopathy problems with hetastarch) I think doctors have a vague uneasiness with hetastarch.

Steve

btim.dyn.ml.org
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